BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM

    MDR report key: 3803248 · Received May 9, 2014

    Report

    Report Number
    2024168-2014-02979
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 15, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED PREMATURE DEPLOYMENT WAS CONFIRMED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF THE ABSOLUTE PRO VASCULAR 6.0/40MM/135CM STENT DELIVERY SYSTEM THE STENT WAS OBSERVED TO BE PROTRUDING FROM THE DEPLOYMENT SHEATH. THE DEVICE WAS NOT USED ON THE PATIENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281992 ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM NIO AV-TEMECULA-CT 3102561

    Patients

    Seq Age Sex Outcome Treatment
    1